Positive news today from St. Jude Medical (NYSE:STJ) about FFR as a clinical decision-making tool. The company announced that it is stopping enrollment in its FAME II trial after only 2/3 of the planned patients were included. Why? Because the interim data so clearly favor the use of Fractional Flow Reserve (FFR) to guide stenting (PCI) in stable angina patients that the independent Data Safety Monitoring Board (DSMB) for the trial has concluded that it would be unethical to continue to randomize patients to optimal medical therapy (OMT) alone. Turns out that patients receiving OMT only experienced a highly statistically significant increased risk of hospital readmission and urgent revascularization.

Wait a minute! Did they say that using optimal medical therapy alone was unethical for the treatment of stable angina patients? That's pretty big news!

What about the findings of the 2007 COURAGE Trial which were interpreted to show quite a different picture: namely that in stable patients, stenting added nothing more than costs. Although those results were hotly contested by the interventional cardiology community and questions were raised about the inclusion criteria and other aspects of COURAGE, the study had a significant impact on the treatment of stable patients and the use of stents dropped precipitously over the next year.

In fact anyone following "Stent News" for the past couple of years would see that the main issues in the headlines have to do with appropriateness of PCI, cardiologists accused of over-stenting, etc.

So what is one to make of today's news? Is this a reversal of COURAGE? (And possibly a "reversal of fortune" for stent manufacturers?)

The answer is well, sort of: not so much a reversal, but rather a refinement. The real answer has to do with something that I and Angioplasty.Org have been advocating and evangelizing about for years now: better decision-making tools. If you visit our "Intravascular Guidance Center", you'll see many articles on the issue of FFR and how its use can improve patient outcomes AND reduce costs at the same time. One of my most recent pieces is, "FFR: Why Isn't everyone Using It?" -- and that's a great question. And now it seems an ethical question, as well.

So, back to COURAGE. In COURAGE, the decision to treat was guided by angiography alone, what Dr. Gary Mintz has called a "silhouette-o-gram." Patients with a 70% or greater blockage, as seen on the angiogram, were eligible for randomization to either OMT or to OMT plus PCI. The results showed no difference in outcomes between the two therapies, leading the medical community to conclude that stenting added nothing in the treatment of stable patients. I've often quoted the then-President of the American Heart Association proclaiming, "Hundreds of thousands of patients may be getting unnecessary stents." Got the picture?

Two years later, Nico Pijls and his team showed in FAME that using FFR to measure the severity of the lesion, instead of angiography, led to 1/3 better outcomes and 1/3 less stenting! So FAME II was devised to mash up these two studies: in effect FAME II would be COURAGE using FFR to decide on stenting, rather than angiography.

And the result? Well today's news shows pretty strongly that FFR-guided PCI is safer, better and, by extension, cheaper. It's also the opinion of many, including several Wall Street analysts, that these data are going to strengthen the interventional approach to the treatment of coronary artery disease. For example, Larry Biegelsen of Wells Fargo stated:

"We think the Fame II results are good news for PCI in general because they will support the use of PCI in stable patients."

And Leerink Swann's Rick Wise wrote in a note:

"the FAME II data -- which includes single, double, and
triple vessel disease -- possibly invalidates some COURAGE conclusions
and suggests that using the right diagnostic tool like FFR as well as DES
(PCI procedure) provides patients a better outcome. Again, this could be
very positive for the PCI market -- encouraging interventional cardiologists
to be more aggressive with stenting when well-validated with a tool like
FFR...."

FFR catheters are manufactured by two companies: St. Jude Medical (NYSE:STJ) and Volcano Corporation (NASDAQ:VOLC). The market is pretty much split 50/50 and this is great news for both companies -- Volcano's stock rose 6.75% today; St. Jude's was up 1.68% -- Volcano is a smaller company and FFR constitutes a much greater piece of their pie.

Positive for companies, but what about patients? Well, as of right now, the use of FFR can help eliminate the concern over "unnecessary stenting". If the FFR shows a significant blockage in the artery (measured by the intracoronary pressure, and not guessed at by looking at a 2-dimensional shadow X-ray image) then the physician and patient can be reassured that stenting can be beneficial.

Of course, this is very preliminary data and compiled analysis will not be presented until later this year at a cardiology meeting TBD. And the FAME II patients will be followed for up to five years. This follow-up data will be very important because it may (and I stress "may") show a mortality difference between PCI and OMT, when guided by FFR, that is.

For now, I have a big question. If, as was announced today, the Safety Board judged that it would be unethical to continue randomizing patients to OMT alone, once FFR showed a significant blockage, is it "ethical" to be subjecting patients to invasive angiography and NOT use FFR? Did you know that FFR is used in less than 20% of cases?

FFR is currently rated as a Class 1A decision tool in the European Guidelines, but only a Class 2A in the U.S. Perhaps these new data will provide the push needed to upgrade FFR as a treatment tool -- and then, most importantly, to fully reimburse its use: something that may clearly save money AND benefit patients.